510(k) · Cleared
Recalled · Class II · 2016E-Z Lubricating Jelly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chester Labs, Inc. · KMJ Lubricant, Patient
Cleared on May 7, 2004 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled once.
- Decided
- May 7, 2004
- Review
- 14 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK041060 E-Z Lubricating JellyChester Labs, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK092488 Dynarex Sterile Lubricating JellyDynarex Corporation · 2009 · Recalled
- Descendant · cites it directly · 1 of its ownK073684 Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK142473 Lubricating JellySion Biotext Medical, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK113689 Dukal Lubricating JellyDukal Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK112110 Sterile Lubricating JellyJianerkang Medical Dressing Company · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092488Dynarex Sterile Lubricating JellyDynarex Corporation · 2009 · cites it directly3descendants
- K073684Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd. · 2008 · cites it directly1descendant
- K142473Lubricating JellySion Biotext Medical, Ltd. · 2015 · 2 generations on0descendants
- K113689Dukal Lubricating JellyDukal Corporation · 2012 · 2 generations on0descendants
- K112110Sterile Lubricating JellyJianerkang Medical Dressing Company · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041060 | E-Z Lubricating Jelly | Chester Labs, Inc. | 2004 | — |
| +1 | K092488 | Dynarex Sterile Lubricating Jelly | Dynarex Corporation | 2009 | 1 |
| +1 | K073684 | Sheffield Pharmaceuticals (Sterile) Lubrigel | Sheffield Industries, Div. of Faria, Ltd. | 2008 | 1 |
| +2 | K142473 | Lubricating Jelly | Sion Biotext Medical, Ltd. | 2015 | — |
| +2 | K113689 | Dukal Lubricating Jelly | Dukal Corporation | 2012 | — |
| +2 | K112110 | Sterile Lubricating Jelly | Jianerkang Medical Dressing Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2016 | Class II | Z-0984-2017 | Process control | Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092488 (Dynarex Corporation, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KMJ
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMJ
1in 2025
MAUDE reports naming product code KMJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 3 | 86 | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 1 | — | 12 | 7 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 1 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
E-Z Lubricating Jelly is a medical device intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
E-Z Lubricating Jelly (sterile) is a medical device Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field Is required.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041060: E-Z Lubricating Jelly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026